Applies to eravacycline: intravenous powder for solution.
Serious side effects of Eravacycline
Along with its needed effects, eravacycline may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking eravacycline:
Less common
- Bleeding wound
- blurred vision
- confusion
- diarrhea
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- red, tender, or oozing skin at the incision site
- sweating
- unusual tiredness or weakness
Rare
- Black, tarry, stools
- bloating
- chest pain
- chills
- constipation
- cough
- dark urine
- difficult or labored breathing
- fast, irregular, pounding, or racing heartbeat or pulse
- fever
- hives, itching, skin rash
- hoarseness
- indigestion
- irritation
- joint pain, stiffness or swelling
- loss of appetite
- lower back or side pain
- mood or mental changes
- muscle cramps in the hands, arms, feet, legs, or face
- nausea
- numbness and tingling around the mouth, fingertips, or feet
- painful or difficult urination
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale skin
- redness of the skin
- seizures
- sore throat
- stomach cramps
- swelling of the eyelids, face, lips, hands, or feet
- tightness in the chest
- tremor
- troubled breathing or swallowing
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- vomiting
- yellow eyes or skin
Other side effects of Eravacycline
Some side effects of eravacycline may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Dry, red, hot, or irritated skin
Rare
- Anxiety
- change in taste
- discouragement
- feeling sad or empty
- loss of interest or pleasure
- loss of taste
- trouble concentrating
- trouble sleeping
For Healthcare Professionals
Applies to eravacycline: intravenous powder for injection.
General
The most common side effects were infusion site reactions, nausea, and vomiting. This drug was discontinued due to side effects in 2% of patients (compared to 2% for comparator); discontinuation was most often due to gastrointestinal disorders.[Ref]
Cardiovascular
Common (1% to 10%): Hypotension, thrombophlebitis (includes thrombophlebitis, infusion site thrombosis), phlebitis (includes phlebitis, infusion site phlebitis, superficial phlebitis, injection site phlebitis)
Frequency not reported: Palpitations
Dermatologic
Uncommon (0.1% to 1%): Rash, hyperhidrosis
Tetracycline class:
-Frequency not reported: Photosensitivity
Gastrointestinal
Common (1% to 10%): Nausea, vomiting, diarrhea
Uncommon (0.1% to 1%): Pancreatitis
Frequency not reported: Acute pancreatitis, pancreatic necrosis, increased amylase, increased lipase
Antibiotic class:
-Uncommon (0.1% to 1%): Treatment-related diarrhea
-Frequency not reported: Pseudomembranous colitis
Hematologic
Frequency not reported: Prolonged activated partial thromboplastin time, decreased WBC count, neutropenia
Hepatic
Uncommon (0.1% to 1%): Increased ALT, increased AST, hyperbilirubinemia
Frequency not reported: Increased GGT
Hypersensitivity
Uncommon (0.1% to 1%): Hypersensitivity
Local
Common (1% to 10%): Infusion site reactions (includes catheter/vessel puncture site pain, infusion site extravasation, infusion site hypoesthesia, infusion/injection site phlebitis, infusion site thrombosis, injection site/vessel puncture site erythema, phlebitis, superficial phlebitis, thrombophlebitis, vessel puncture site swelling, injection site pain/discomfort, injection site swelling/inflammation), infusion site phlebitis
Uncommon (0.1% to 1%): Infusion site thrombosis, vessel puncture site erythema, infusion site hypoesthesia
Metabolic
Frequency not reported: Hypocalcemia
Nervous system
Uncommon (0.1% to 1%): Dizziness, headache
Frequency not reported: Dysgeusia
Tetracycline class:
-Frequency not reported: Pseudotumor cerebri
Other
Common (1% to 10%): Wound dehiscence
Frequency not reported: Chest pain
Antibiotic class:
-Frequency not reported: Overgrowth of nonsusceptible organisms (including fungi)
Tetracycline class:
-Frequency not reported: Antianabolic action (leading to increased BUN, azotemia, acidosis, hyperphosphatemia)
Psychiatric
Frequency not reported: Anxiety, insomnia, depression
Renal
Frequency not reported: Decreased renal clearance of creatinine
Respiratory
Frequency not reported: Pleural effusion, dyspnea
